Central nervous system treatment device and methodology

ABSTRACT

The invention relates to a method of central nervous system pathology treatment through selective hypothermia. Brain and spinal cord cooling is achieved through a closed loop catheter system inserted directly into the cerebrospinal fluid space. The catheter comprises of a portion that dilates in a pulsatile or peristaltic fashion and facilitates circulation of the cooled cerebrospinal fluid.

BACKGROUND OF THE INVENTION

The current invention relates to regulation of the temperature in thebrain and spinal cord. The invention describes a method and apparatusfor altering the temperature of the brain and/or the cerebrospinal fluidin the ventricles of the brain and surrounding the brain and spinalcord. Hypothermia has been shown to provide cerebral and spinal cordinjury protection from either trauma, ischemia, or hypoxia. Ischemia mayoccur from cardiac arrest, cardiac failure, stroke, head or spinal cordinjury, aneurysm surgery, cardiac surgery, and aortic or carotidsurgery. Hypothermia is also effective in reducing increasedintracranial pressure from cerebral swelling. The mechanisms involved inhypothermic cerebral protection are several-fold and include 1)reduction in cerebral glucose and oxygen metabolism and decreasinglactate content following injury, 2) preventing disruption of the bloodbrain barrier and consequently reducing cerebral edema, 3) reduction ofendogenously toxic neurotransmitters like glutamate, glycine, aspartate,acetylcholine, and norepinephrine into the brain after injury, 4)inhibit excessive calcium entry and intracellular calcium overload intoneurons, 5) protecting membrane structural proteins likemicrotubule-associated protein-2, and 6) preventing diffuse axonalinjury following brain trauma.

In general, the human brain and spinal cord are maintained at a constanttemperature of approximately 37 to 38 degrees celsius. Hypothermia isconsidered mild when the body temperature is 33 to 35 degrees celsius,moderate between the temperatures of 28 to 32 degrees, and severe in thetemperature range of 24 to 28 degrees celsius. Most studies in humanshave involved mild to moderate systemic hypothermia mainly because ofthe significant side effects that occur from induced systemichypothermia. These include infection, cardiac arrhythmias, coagulopathy,renal failure, as well as rewarming shock. In order to avoid thesecomplications the degree and duration of hypothermia has been shortenedthereby limiting its effectiveness.

Generally, cooling of the brain has been accomplished through whole bodycooling with use of a cooling blanket, immersing the patient in ice, orcooling the blood through a cardiopulmonary bypass machine. A fewmethods have been described regarding selective brain and spinal cordhypothermia. These involve cooling the arterial vessel or blood supplyto the brain or external cooling helmets, each with its own significantlimitations.

Several catheters have been developed to induce systemic hypothermia byinserting them into the bloodstream. More recently catheters have beendeveloped that can be inserted into the arterial vessels to the brain toinduce selective brain hypothermia. These catheters are limited in theirsize and functionality by the small vessel lumen as well the inabilityto cool all the four major arterial vessels supplying blood to the brainand are unable to cool the spinal cord via this methodology. They alsocarry the risk of ischemic and thromboembolic stroke by either impairingthe blood flow to the brain or dislodging clots that can develop inintra-arterial catheters.

External cooling helmets have limited effectiveness since the blood tothe cooled scalp does not circulate into the brain and returnssystemically which along with the thick skull dilutes the hypothermiceffect to the brain.

Selective brain and spinal cord cooling with insertion of closed loopsystem catheters into the ventricular, subdural or epidural space wasfirst described in U.S. Pat. No. 6,699,269 to Khanna. It also describesa catheter that expands with circulation of a coolant without directcontact of the coolant with the central nervous system. This avoids theside effects and complications seen from other methods of cooling. Italso circumvents infection and fluid overload with exacerbation of brainswelling that can be potentially encountered with cooling systemsinvolving circulating the cerebrospinal fluid. This patent also relatesa methodology for cerebrospinal fluid drainage to relieve an increase inICP. U.S. application Ser. No. 11/418,849 by the applicant relates amethod and apparatus for selective central nervous system cooling with aballoon catheter. Although the balloon is used to increase the surfacearea of cerebrospinal fluid contact to facilitate heat exchange, all ofthe prior art relates dilation of the balloon to a preset volume.Balloon dilation inside the central nervous system has a significantpotential for raising the intracranial pressure especially when there ispathology and/or swelling in the brain and spinal cord. Dilating theballoon to a preset volume may not be the best methodology sincedifferent patients will tolerate different levels of central nervoussystem volume increase. Even a few milliliters of volume increase insidethe head or spine with a swollen brain and spinal cord can risk severefurther injury. Another limitation of the prior technique is cooling ofthe cerebrospinal fluid in a stagnant cerebrospinal fluid which limitsthe extent of selective central nervous system cooling. There remains aneed for faster and more uniform methodology for selective centralnervous hypothermia induction and central nervous system pathologytreatment.

SUMMARY OF THE INVENTION

The invention provides a method and apparatus for treatment of centralnervous system pathology. This is achieved by performing selectivehypothermia to the brain and/or the spinal cord for injury protectionwithout the need for systemic cooling as well as drainage any excesscerebrospinal fluid or hemorrhage through the device.

For selective brain cooling, in one embodiment of the present invention,a flexible heat exchange catheter is inserted into the cerebrospinalfluid space. The catheter has an inflow and outflow lumen forcirculation of a coolant by an external regulator. The portion of thecatheter in contact with the cerebrospinal fluid can expand into aballoon in a peristaltic format. The peristaltic expansion andcontraction creates pulsations in the cerebrospinal fluid and circulatesthe cooled cerebrospinal fluid, thereby uniformly cooling the brain andspinal. Cerebrospinal fluid is produced by the choroid plexus inside thebrain lateral ventricles. The two lateral ventricles communicate witheach other through the third ventricle which also opens into the fourthventricle. The lateral ventricles also communicate with thecerebrospinal fluid in the basal cisterns surrounding the brain stemthrough the choroidal fissure. The fourth ventricle communicates withthe subarachnoid space through the foramen of Magendie and Luschka. Thesubarachnoid space extends from around the brain, brainstem, and spinalcord. Essentially all of the central nervous system structures and inparticular the brain and spinal cord either are surrounded by or containcerebrospinal fluid. A methodology that not only cools the cerebrospinalfluid but also facilitates circulation of the cooled cerebrospinal fluidprovides for a faster and more uniform selective central nervous systemhypothermia induction.

In another embodiment, the catheter has three lumens with two lumensused for circulation of the coolant that communicate at the distal endof the catheter. The third lumen has holes at the distal end that allowsfor drainage of cerebrospinal fluid as well as intracranial pressuremonitoring similar to a ventriculostomy. An external regulator controlsthe extent of balloon dilation and coolant rate circulation bymaintaining the central nervous system pressure within a desirablerange. In another embodiment of the catheter, a balloon located at thedistal end of the catheter expands when the coolant fluid is circulated.The expansion also opens the third lumen distal holes further tomaintain patency.

In other embodiments, the balloon expansion is controlled and can alsoconform to the space of the central nervous system location that it isplaced in as long as the central nervous system pressure remains withina desirable range preferably within normal limits of less than 15 mm Hg.

The catheters are designed to allow an inert coolant to circulate in thelumens without direct exposure to the brain or spinal cord and therebyaltering the brain or spinal cord temperature. This allows for selectivecooling of the brain and spinal cord for treatment of injury fromtrauma, ischemia, hypoxia and/or cerebral swelling.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of one embodiment the device in the brainlateral ventricle.

FIG. 2a is a schematic view of the central nervous system andcerebrospinal fluid.

FIG. 2b is a schematic view of the device in the spinal subarachnoidcerebrospinal fluid space.

FIG. 3a is a side view of the device.

FIG. 3b is a longitudinal cross-sectional view of the device.

FIG. 4 is a longitudinal cross-sectional view of the device withpartially dilated balloon.

FIG. 5 is a longitudinal cross-sectional view of the device with fullydilated balloon.

FIG. 6 is a partial sectional view of the device.

FIG. 7 is a cross-sectional view of the device.

FIG. 8a is a longitudinal cross-sectional view of another embodiment ofthe device.

FIG. 8b is a longitudinal cross-sectional view of the device with theballoon in a contracted position.

FIG. 9a is a longitudinal cross-sectional view of the device with theballoon in a partially dilated position.

FIG. 9b is a longitudinal cross-sectional view of the device with theballoon in a fully dilated position.

FIG. 10 is a longitudinal cross-sectional view of another embodiment thedevice with the balloon in a contracted position.

FIG. 11 is a longitudinal cross-sectional view of the device with theballoon in a partially dilated position.

FIG. 12 is a longitudinal cross-sectional view of the device with theballoon in a fully dilated position.

FIG. 13 is a cross-sectional view of another embodiment the devicedepicting direction of coolant flow.

FIG. 14 is a longitudinal cross-sectional view of another embodiment thedevice with the balloon in a partially dilated position.

FIG. 15 is a longitudinal cross-sectional view of the device with theballoon in a partially dilated position.

FIG. 16 is a longitudinal cross-sectional view of the device with theballoon in a fully dilated position.

FIG. 17 is a longitudinal cross-sectional view of another embodiment thedevice with the balloon in a partially dilated position.

FIG. 18 is a partial sectional view of the device.

FIG. 19 is a cross-sectional view of the device.

FIG. 20 is a longitudinal cross-sectional view of another embodiment thedevice with the balloon in a contracted position.

FIG. 21 is a longitudinal cross-sectional view of the device with theballoon in a dilated position.

FIG. 22 is a cross-sectional view of the device with the balloon in acontracted position.

FIG. 23 is a cross-sectional view of the device with the balloon in adilated position.

FIG. 24 is a side view of another embodiment of the device.

FIG. 25 is a side view of another embodiment of the device.

FIG. 26 is a side view of another embodiment of the device.

FIG. 27 is a longitudinal cross-sectional view of another embodiment thedevice with the balloon in a contracted position.

FIG. 28 is a longitudinal cross-sectional view of the device with theballoon in a partially dilated position.

FIG. 29 is a longitudinal cross-sectional view of the device with theballoon in a fully dilated position.

FIG. 30 is a side view of another embodiment the device with the balloonin a contracted position.

FIG. 31 is a side view of the device with the balloon in a dilatedposition.

FIG. 32 is a cross-sectional view of another embodiment the device withthe balloon in a contracted position.

FIG. 33 is a cross-sectional view of the device with the balloon in adilated position.

FIG. 34 is a cross-sectional view of another embodiment the device withthe balloon in a contracted position.

FIG. 35 is a cross-sectional view of the device with the balloon in adilated position.

FIG. 36 is a cross-sectional view of another embodiment the device withthe balloon in a contracted position.

FIG. 37 is a cross-sectional view of the device with the balloon in adilated position.

FIG. 38 is a cross-sectional view of another embodiment the device withthe balloon in a contracted position.

FIG. 39 is a cross-sectional view of the device with the balloon in adilated position.

FIG. 40 is a side view of another embodiment the device with the balloonin a dilated position.

FIG. 41 is a side view of another embodiment the device with the balloonin a dilated position.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In one method of central nervous system pathology treatment, the deviceas shown in FIG. 1, is placed into the ventricle of the brain or thesubarachnoid space of the spine. This allows for cooling of thecerebrospinal fluid and hence the brain and/or spinal cord selectively.The effects of the cooling provide for treatment of swelling, traumatic,hypoxic, and ischemic injuries. These devices can be placed in thelateral ventricles using the standard landmarks or can be preciselyplaced with stereotactic guidance or use of an endoscope or ultrasound.The device 1 is placed into the cerebrospinal fluid in the ventricle 2of the brain 3. Typically a hole is drilled into the skull 4 to accessthe brain and the ventricles through a standard ventriculostomyapproach. The device 1 distal end comprises a balloon placed in thecerebrospinal fluid that allows a greater surface area for heatexchange. The proximal end 5 of the device 1 is connected to a regulatorthat controls the extent of balloon dilation and circulation of thecoolant through the device 1 closed loop cooling system. The regulatoralso monitors ICP and temperature through sensors positioned near theballoon end of the device 1. As shown in FIGS. 2a & 2 b, the brain 6contains cerebrospinal fluid inside the ventricles 8 and is alsosurrounded by cerebrospinal fluid 9 which is in communication with thecerebrospinal fluid 10 around the spinal cord. Cooling of thecerebrospinal provides for selective hypothermia of the brain and spinalcord. Facilitating circulation of the cooled cerebrospinal fluidprovides for a faster brain and spinal cord cooling. The cerebrospinalfluid circulation can be facilitated by a device 1 placed in thecerebrospinal fluid 10 with a balloon that dilates and contracts in analternating sequence or a peristaltic format as described in the currentinvention. This sequential dilation and contraction circulates thecerebrospinal fluid inside and outside the brain and spinal cord. It isalso very prudent that the extent of the device balloon dilation placedinside the central nervous system be controlled so that the ICP is notincreased in this process and also avoid compressive forces on the brainor spinal cord. A balloon that conforms to the shape of the space it hasbeen placed inside the central nervous system allows for the bestpossible likelihood of not increasing the ICP with balloon dilation. Theballoon shape can be round, oval, cylindrical or conform to the shape ofthe portion of the lateral ventricle it is placed in to avoidcompression against the ventricle wall. The preferred spinalcerebrospinal fluid space location of the device is in the lumbarlocation but can also include cervical or thoracic spine. The device canbe placed post-operatively after either a laminectomy, discectomy, orcorpectomy. The device can also be placed through a percutaneoustechnique similar to placement of a spinal drain or lumbar puncture.X-ray or fluoroscopy can also be used to locate the correct spinalplacement of the device.

In one embodiment as shown in FIGS. 3-7, the device is in the contractedposition of the balloon 16 as shown in FIGS. 3a & 3 b and dilatedballoon positions as shown in FIGS. 4 & 5. The device comprises anoutside wall 11 and an inside wall 12. The inside wall divides the lumenof the device into two parts 15 that communicate at the distal end 14.The lumens circulate a coolant through a regulator/coolant placedexternal to the body. The device distal end is placed inside the desiredcentral nervous system location. The distal end also comprises of one ormore sensors 13 (pressure, temperature, etc). FIG. 4 shows the distalend 16 of the device in a partially dilated balloon position and FIG. 5shows the distal balloon 16 completely dilated. The pulsating dilationand contraction of the balloon 16 circulates the cerebrospinal fluidoutside the balloon and the circulating coolant in the lumens cools thecerebrospinal fluid. The increased surface area provided by the balloonexpansion allows for a greater degree of heat exchange.

In another embodiment as shown in FIGS. 8 & 9, the device comprises acatheter with a wall 17 and a central lumen 20 surrounded by a lumen 18and 19. The lumen 20 communicates with the lumen 18 and 19 through holes21 at the distal end of the catheter and circulates a coolant with thearrows in FIG. 8a depicting the direction of the coolant flow. Thecatheter also contains sensors 22 at the distal portion. The contractedshape of the balloon is shown in FIGS. 8a & 8 b and the expanded shapeof the balloon 23 is shown in FIGS. 9a & 9 b. The balloon 23 ispartially dilated in FIG. 9a and completely dilated in FIG. 9b . Theballoon 23 expands and contracts in a pulsating format with circulationof the coolant by an external coolant pump regulator. This pulsatingexpansion and contraction of the balloon creates a wave in thecerebrospinal fluid where the balloon tip is placed and facilitatescirculation of the cooled cerebrospinal fluid throughout the centralnervous system.

In another embodiment of the device as shown in FIGS. 10-12, thecatheter comprises a wall 24 with a central lumen 27 that communicateswith the lumen 25 and 26 surrounding the central lumen 27 through holes28 and 29. The holes in the distal portion of the central lumen 27 arelarger in diameter proximally 28 and decrease in diameter sequentiallydistally 29. The coolant is circulated through the lumen 27 and exitsinto lumen 25 and 26 through the holes 28 and 29 in a closed loopsystem. The distal catheter wall 31 can dilate if the pressure in thelumen is increased by an external coolant regulator. The larger holes 28proximally and smaller holes 29 distally in the central lumen 27 allowlarger coolant flow more proximally into lumen 25 and 26 therebydilating the balloon in a peristaltic format as shown in FIGS. 11 & 12.In FIG. 11, the top portion of the balloon 31 is dilated more proximallyand the dilation wave progresses more distally as seen with the bottomportion of the balloon 32. This peristaltic format of balloon dilationwith circulation of the coolant moves the cooled cerebrospinalsurrounding the balloon and facilitates central nervous system cooling.

In another embodiment of the catheter as shown in FIG. 13, the centrallumen 27 is surrounded by lumen 25 with an outer wall 24. The centrallumen 27 communicates with surrounding lumen 25 at the distal catheterend through holes 34 and 35 which enlarge circumferentially. Thisenables the wall 24 to dilate into a balloon in a peristaltic andspiraling format with circulation of the coolant 33 (arrows depictingflow direction). This balloon dilation format further facilitatescirculation of the cooled cerebrospinal fluid surrounding the balloon.

In another embodiment of the catheter as shown in FIGS. 14-19, thecentral lumen 37 is surrounded by a lumen 39 and catheter wall 36. Thecentral lumen is attached to the outer wall by a membrane 47. Thecentral lumen 37 comprises holes 40 and 41 at the distal end. The holesare larger proximally 41 and taper to a smaller size 40 distally. Theholes 41 and 40 also taper from a larger to smaller size in a spiralingformat. With circulation of the coolant the outer catheter wall expandsinto a balloon from proximally to distally in a spiraling andperistaltic format. FIG. 14 shows the balloon 38 dilation in the initialphase, FIG. 15 shows circumferential balloon dilation 38, and FIG. 16shows the peristaltic balloon dilation 38 moving from proximal to thedistal end.

FIG. 17 illustrates another embodiment of the spiral peristaltic balloondilation catheter. The central lumen 42 comprises holes 43 and 44 at thedistal end surrounded by a lumen 46 and balloon wall 45. The lumen 42holes enlarge from a smaller 43 to larger 44 sizes from proximal todistal end in a spiraling format. Circulation of the coolant dilates theballoon 45 in a spiral peristaltic manner from distally to proximally.

In another embodiment of the device as shown in FIGS. 20-23, thecatheter also comprises a drainage lumen with ports at the distal end.The lumen 49 and 54 is contained between the catheter outer wall 48 andthe inner wall 56. The inner lumen 50 is used for drainage ofcerebrospinal fluid and/or hemorrhage through ports 51. This lumen canalso be used to monitor intracranial pressure similar to aventriculostomy drain. The lumen wall 56 is attached to the lumen wall48 with membrane 55. A coolant is circulated in the lumens 49 and 54which communicate at the distal end 53 with a closed loop system. Atemperature and/or pressure sensor 52 is positioned at the tip or anyother location on the catheter to monitor central nervous systemtemperature and/or pressure. The distal portion of the catheter iscapable of dilating into a balloon with circulation of the coolant undercontrolled pressure with dilation of the lumen 49 and 54 spaces as shownin FIGS. 21 and 23.

The balloons located at the distal catheter ends can conform to theshape of the central nervous system space that they are placed in. Theballoon walls are compliant and conform to the shape most amenable tonot increasing the intracranial pressure. FIGS. 24-26 illustrate thevarious embodiments with different balloon shapes including but notlimited to the shapes illustrated. FIG. 24 shows an inflow and outflowcoolant circulation lumen 57 with a round balloon 58, FIG. 25 shows aninflow and outflow lumen 59 with an oval balloon 60, and FIG. 26illustrates an inflow and outflow lumen 61 with a cylindrical balloon62. Other balloon shapes can comprise of a shape of the lateralventricle, post-surgical brain cavity, cisterna magna, subdural,epidural or subarachnoid space in the head or spine. The balloons candilate parallel to the longitudinal catheter axis or at any other anglefrom 0 to 360 degrees.

In another embodiment of the device as shown in FIGS. 27-29, thecatheter comprises double balloons at the distal heat exchange end. Thecatheter wall 63 encloses lumens 64 and 69 with a central lumen 70 and atemperature and ICP sensor 68. The central coolant inlet lumen comprisesof holes 65 and 67 with a portion in between without holes 66. Pumpingof the coolant through the inlet lumen 70 circulates the coolant throughholes 65 and 67 with the coolant entering outlet lumens 64 and 69. Theballoons 71 and 72 dilate depending on the pressure under which thecoolant is pumped. FIG. 28 illustrates the partial dilation of balloon71 and complete dilation of balloon 72. As more of the coolant iscirculated under higher pressure, both the balloons dilate as shown inFIG. 29. This sequential balloon dilation creates a wave in thecerebrospinal fluid surrounding the balloons and facilitates circulationof the cooled cerebrospinal fluid.

In another embodiment of the device as shown in FIGS. 30 & 31, thecatheter distal end comprises of thermal heat conductors 74 in the wall75. The proximal portion 73 contains and inlet and outlet lumen forcoolant circulation and the distal heat conductor portion of the wall 75can dilate into a balloon as shown in FIG. 31 with the flow of thecoolant under pressure. The thermal heat conductors 74 can also compriseof pressure sensors which gauge the extent of balloon dilation bymaintaining the central nervous system pressure within a desired rangeand avoid undue pressure on the surrounding brain.

In another embodiment of the device as shown in FIGS. 32 and 33, thedistal balloon end of the catheter wall 80 comprises of pressure sensors75. The multiple balloons are arranged in a circumferential format andhave an individual inlet 76 and 79 and outlet 77 and 78 ports forcoolant circulation. The extent of each balloon 77, 78 dilation isdictated by the pressure on each balloon sensor 75 with the attempt toavoid pressure against the ventricle wall or central nervous system aswould normally be undertaken with blind dilation in the prior art. Inalternative embodiments, the pressure sensor 75 can also comprise a dualfunction as a thermal conductor to facilitate heat exchange. FIG. 32shows the contracted position of the balloons 77 & 78 and FIG. 33 showsthe dilated position of the balloons 77 & 78.

In another embodiment of the device as shown in FIGS. 34 and 35, thedistal balloon end of the catheter comprises of balloons 85 and 86 eachwith a coolant inflow lumens 84 and 83 and outflow lumens 81 and 82. Theoutflow lumens 81 and 82 dilate into balloons once the coolant iscirculated as shown in FIG. 35.

In another embodiment of the balloon catheter as shown in FIGS. 36 & 37,the central lumen 90 comprises a wall 91 and circulates a coolant intothe multiple balloon lumens 87, 88, and 89 which dilate depending on thepressure of the coolant circulation as shown in FIG. 37. The balloonwall is compliant and adapts to the shape of the path of leastresistance in the central nervous system. In alternative embodiments, asshown in FIGS. 38 and 39, the balloons 92, 94, and 96 have individualinflow 98, 95, 97 and outflow coolant lumens. The central lumen 93communicates with cerebrospinal fluid through ports 99 for drainage andpressure monitoring. FIG. 38 shows the contracted position of theballoons 92, 94, and 96 and FIG. 39 shows the expanded position.

FIG. 40 illustrates double balloons 100 and 102 with drainage ports 104in the catheter wall 101 between the balloons. A coolant is circulatedthrough a closed loop system through the catheter proximal portion 103connected to a cooler. FIG. 41 illustrates a balloon cooling catheter108 with drainage ports 107. The drainage ports 107 can also beincorporated into the balloon wall 105.

The methodology and device described provides for treatment of anycentral nervous system pathology including but not limited to treatmentof increased intracranial pressure, brain swelling or edema, spinal cordedema, trauma, brain injury, skull fracture, stroke, ischemia, hypoxiafollowing respiratory or cardiac arrest, tumors, hemorrhage, infection,seizure, spinal cord injury, spine fractures, arteriovenousmalformations, aneurysms, aortic artery surgery ischemia protection,spinal stenosis, herniated disc, and scoliosis surgery. The device canbe placed intracranial following drilling of a hole in the skull via atwist drill, burr hole placement, or craniotomy/craniectomy. It can beplaced inside the spinal canal in the epidural, subdural or subarachnoidspace through a percutaneous technique or following alaminotomy/laminectomy. Placement of the device intracranially orintraspinally can be further facilitated by radiographic guidance(fluoroscopy), ventriculograms, cisternograms, ultrasound, frame basedor frameless stereotactic navigation systems, or endoscopy. Thepreferred location of the device is in the cerebrospinal fluid space inthe lateral ventricle, subarachnoid space of the brain surface, andlumbar intra-thecal space. Other locations include in the surgicalresection bed following craniotomy for removal of brain tumor orhemorrhage and spinal epidural or intrathecal space following alaminectomy. The catheter device can also be secured to the skull by ahollow bolt. The closed loop cooling system selectively cools thecentral nervous system without serious side-effects of generalized bodycooling and in some embodiments also provides for drainage of fluid(cerebrospinal fluid or hemorrhage).

Sensors can be placed in the distal portion of the device positionedinside the central nervous system. These sensors can either be in onelocation or in multiple locations on the catheter wall. In the preferredembodiment, the sensors monitor pressure and temperature. In otherembodiments water sensors can also be positioned to detect cerebrospinalfluid location inside the ventricle to confirm correct catheter locationsince cerebrospinal fluid predominantly comprises of water. Similarly,impedance sensors can also provide for confirmation of location as theimpedance changes from brain to a cerebrospinal fluid location as thecatheter is advanced into the lateral ventricle during placement. Othersensors can comprise of cerebrospinal fluid marker sensors, osmolaritysensors, oxygenation sensors, carbonation sensors, metabolite sensors,and pH sensors.

The device with the capability of cooling and circulation of thecerebrospinal fluid provides for selective cooling of the brain andspinal cord. Since the cerebrospinal fluid is in communication frominside the brain to the outer surface of the brain and spinal cord,placement of the device intracranially not only cools the brain but alsothe spinal cord. Similarly, cooling of the brain can also be achieved byplacement of the device inside the spinal canal. Alternatively, onedevice can be placed intracranially and another in the spinal canal toincrease the extent of selective central nervous system cooling.

While the invention and methodology described herein along with theillustrations is specific, it is understood that the invention is notlimited to the embodiments disclosed. Numerous modifications,rearrangements, and substitutions can be made with those skilled in theart without departing from the spirit of the invention as set forth anddefined herein.

What is claimed is:
 1. A device for treating a central nervous system,the device comprising: an elongated catheter including an outside wallhaving a first lumen formed therein, and an inside wall having a secondlumen formed therein, wherein the inside wall divides the first lumeninto two parts that communicate at a distal end of the elongatedcatheter, the two parts of the first lumen being adapted to allow acoolant to circulate therethrough, wherein a distal portion of theoutside wall includes a plurality of ports that communicate with thesecond lumen and the outside environment; and wherein the two parts ofthe first lumen communicate at a position closer to a distal tip of theelongated catheter than the plurality of ports in an axial direction ofthe elongated catheter.
 2. The device of claim 1, wherein the distalportion of the outside wall is capable of expansion.
 3. The device ofclaim 2, wherein the distal portion of the outside wall is capable ofexpanding into one or more of the following shapes: an oval shape, around shape, a cylindrical shape, a triangular shape, a double balloonshape, a helical shape, at an angle to the elongated catheter, a shapeof a portion of or an entire lateral ventricle, a shape of a frontalhorn of a lateral ventricle, a shape of body of a lateral ventricle, ashape of an occipital horn of a lateral ventricle, a shape of a thirdventricle, a shape of an operative area in a brain or spine, a shape ofa cisterna magna, and a shape of a spinal canal.
 4. The device of claim2, wherein the distal portion of the outside wall is expandable in aperistaltic manner.
 5. The device of claim 2, wherein the distal portionof the outside wall is expandable in a pulsating manner.
 6. The deviceof claim 1, further comprising one or more of the following: a watersensor, a pressure sensor, an osmolarity sensor, a temperature sensor,an impedance sensor, an oxygenation sensor, a carbonation sensor, ametabolite sensor, a pH sensor, and a cerebrospinal fluid sensor.
 7. Thedevice of claim 1, wherein the first lumen and the second lumen arecoaxial.
 8. The device of claim 1, the distal portion of the outsidewall comprises at least one balloon that is expandable.
 9. The device ofclaim 1, wherein the outside wall defines a portion of the first lumenand is an outermost wall of the elongated catheter.
 10. A device fortreating a central nervous system, the device comprising: a first wallhaving an outer lumen formed therein; a second wall having an innerlumen formed therein; and a membrane connecting the second wall to thefirst wall and dividing the outer lumen into two parts, wherein the twoparts of the outer lumen communicate at a distal end of the device,wherein the first wall includes at least one port at the distal end thatcommunicates with the inner lumen and not the outer lumen, and whereinthe two parts of the outer lumen communicate at a position closer to adistal tip of the device than the at least one port in an axialdirection of the device.
 11. The device of claim 10, wherein the distalend of the first wall is capable of expansion.
 12. The device of claim11, wherein the distal end of the first wall is capable of expandinginto one or more of the following shapes: an oval shape, a round shape,a cylindrical shape, a triangular shape, a double balloon shape, ahelical shape, at an angle to the elongated catheter, a shape of aportion of or an entire lateral ventricle, a shape of a frontal horn ofa lateral ventricle, a shape of body of a lateral ventricle, a shape ofan occipital horn of a lateral ventricle, a shape of a third ventricle,a shape of an operative area in a brain or spine, a shape of a cisternamagna, and a shape of a spinal canal.
 13. The device of claim 11,wherein the distal end of the first wall is expandable in a peristalticmanner.
 14. The device of claim 13, wherein the inner lumen and theouter lumen are coaxial.
 15. The device of claim 10, the distal end ofthe first wall comprises at least one balloon that is expandable. 16.The device of claim 10, wherein the distal end of the first wall isexpandable in a pulsating manner.
 17. The device of claim 10, furthercomprising one or more of the following: a water sensor, a pressuresensor, an osmolarity sensor, a temperature sensor, an impedance sensor,an oxygenation sensor, a carbonation sensor, a metabolite sensor, a pHsensor, and a cerebrospinal fluid sensor.
 18. The device of claim 10,wherein the first wall defines a portion of the outer lumen and is anoutermost wall of the device.
 19. A method of central nervous systemtreatment, the method comprising: inserting an elongated device into thecentral nervous system, the elongated device including an outside wallhaving a first lumen formed therein, and an inside wall having a secondlumen formed therein, wherein the inside wall divides the first lumeninto two parts that communicate at a distal end of the elongated device,the two parts of the first lumen being adapted to allow a coolant tocirculate therethrough, wherein a distal portion of the outside wallincludes a plurality of ports that communicate with the second lumen andthe outside environment, and wherein the two parts of the first lumencommunicate at a position closer to a distal tip of the elongatedcatheter than the plurality of ports in an axial direction of theelongated catheter; and circulating a coolant through the two parts ofthe first lumen.
 20. The method of claim 19, wherein the central nervoussystem comprises one or more of the following: an intracranial region, aspine, a brain, a spinal cord, a subdural region, a subarachnoid region,an epidural region, an intrathecal region, a cerebral spinal fluid, alateral ventricle, brain ventricles, an operative area in a brain orspine, and a spinal canal.
 21. The method of claim 19, wherein thecentral nervous system treatment comprises treating one or more of thefollowing: hypothermia induction, increased intracranial pressure,trauma, brain injury, skull fracture, stroke, ischemia, hypoxia,hemorrhage, infection, seizure, edema, burr hole surgery, craniotomy,decompressive craniectomy, spinal cord injury, spine fracture, swelling,tumor, vascular malformation, stenosis, herniated disc, scoliosissurgery, and aortic aneurysm surgery.
 22. The method of claim 19,wherein the inserting of the elongated device comprising performing oneor more of the following techniques: craniotomy, burr hole, twist-drillhole, laminectomy, laminotomy, percutaneously, endoscope assisted,stereotactic guidance, and ultrasound guidance.